Telemonitoring for TMD-Related Pain (NCT07764770) | Clinical Trial Compass
CompletedNot Applicable
Telemonitoring for TMD-Related Pain
Italy60 participantsStarted 2025-01-01
Plain-language summary
This prospective randomized clinical trial evaluates the effectiveness of a structured telemonitoring protocol as an adjunct to conservative management in patients with temporomandibular disorder (TMD)-related orofacial pain. Participants receive standardized conservative therapy based on behavioural counselling, habit reversal training, and home-based self-management exercises, with or without structured telemonitoring. Clinical outcomes include pain intensity, mandibular function, and oral behaviours, assessed over a 9-month follow-up period. The study aims to determine whether telemonitoring improves treatment adherence, behavioural modification, and clinical outcomes compared with conventional in-office follow-up.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18-80 years.
* Diagnosis of temporomandibular disorder (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
* Presence of chronic orofacial pain persisting for more than 30 days.
* Diagnosis of myofascial pain involving the masticatory muscles, with or without headache attributed to TMD.
* Ability to use a mobile device compatible with telemonitoring procedures.
Exclusion Criteria:
* Systemic diseases affecting pain perception or neuromuscular function (including autoimmune, neurological, or neoplastic disorders).
* History of severe orofacial trauma.
* Previous major temporomandibular joint surgery.
* Ongoing orthodontic treatment.
* Current use of occlusal splints.
* Current use of muscle relaxants or psychoactive medications.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum pain-free mouth opening (mm)
Timeframe: Baseline (T0), 3 months (T1), and 9 months (T2)
2
Mandibular lateral excursions (mm)
Timeframe: Baseline (T0), 3 months (T1), and 9 months (T2)
3
Protrusive movement (mm)
Timeframe: Baseline (T0), 3 months (T1), and 9 months (T2)
4
Pain intensity assessed using the Visual Analogue Scale (VAS)
Timeframe: Baseline (T0), 3 months (T1), and 9 months (T2)